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A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

Inclusion Criteria


INCLUSION CRITERIA:

Documented B-Cell NHL or mantle cell lymphoma

- CD-20+ tumor

- Indolent NHL: follicular B-cell lymphoma, diffuse small lymphoma, marginal zone
lymphoma

- Maximum of three prior chemotherapy regimens

- Age of at least 18 years at Screening Visit (Site specific requirement may differ)

EXCLUSION CRITERIA:

- Refractory to rituximab, defined as progression of disease while being treated with
rituximab or progression within 6 months of the last dose of rituximab (when given
either as a single agent or in combination)

- Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6
weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to
any agents administered previously

- Use of investigational agents within 28 days of study

- History of prior high dose chemotherapy with allogeneic stem cell support

- History of prior radioimmunotherapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the objective response rate (ORR = CR + PR) to a regimen of SDX-105 plus rituximab in patients with relapsed indolent or mantle cell non-Hodgkin's lymphoma

Outcome Time Frame:

4-6 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

SDX-105-02

NCT ID:

NCT00076349

Start Date:

April 2004

Completion Date:

March 2008

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • NHL
  • Rituxan
  • Mantle Cell
  • mabs
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Southwest Regional Cancer CenterAustin, Texas  78705
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Hubert H. Humphrey Cancer CenterCoon Rapids, Minnesota  55433
Baylor University Medical CenterDallas, Texas  75246
John B. Amos Cancer CenterColumbus, Georgia  31904
Arena Oncology AssociatesGreat Neck, New York  11021
San Diego Cancer CenterVista, California  92083
Wilshire Oncology Medical GroupGlendora, California  91741
Bay Area Cancer Research GroupConcord, California  94520
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
LSU Health Sciences CenterShreveport, Louisiana  71130-3932
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Georgetown University Medical Center - Lombardi Cancer CenterWashington, District of Columbia  20007
Alaska Cancer Research and Education CenterAnchorage, Alaska  99508
USC/Kenneth Norris Jr. Cancer Hospital and Research InstituteLos Angeles, California  90033
Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer CenterStamford, Connecticut  06902-3628
Pasco Hernando OncologyNew Port Richey, Florida  34652
Suburban Hematology & Oncology AssociatesLawrenceville, Georgia  30045
Georgia Oncology Partners Research and Education FoundationMacon, Georgia  31201
Oncology and HematologyMetairie, Louisiana  70006-2921
Beth Israel/Deaconess Medical CenterBoston, Massachusetts  02215
Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/HematologyRochester, New York  14623
ACORN - West Cancer CenterMemphis, Tennessee  38120
Univ. of Virginia Health System-Cancer Center Clinical Trials OfficeCharlottesville, Virginia  22908